Mold findings spark NJ compounding pharmacy recall

Mar 18, 2013 (CIDRAP News) – A New Jersey compounding pharmacy yesterday recalled all of its products after a Connecticut hospital found particulates in the company's magnesium sulfate intravenous (IV) solution that were confirmed to be mold.

MedPrep Consulting, Inc., based in Tinton Falls, N.J., said in press release yesterday from the US Food and Drug Administration (FDA) that it was targeting the recall to hospital pharmacies and related departments, as well as physicians' offices.

Though the contaminated products were made for and distributed to the Connecticut hospital, where five contaminated bags were discovered, the company said it was recalling all of its compounded products because of sterility concerns.

The company first recalled only the magnesium sulfate solution on Mar 16, but it expanded the action to all of its products the next day. The product that contained the mold was 50 mL bags of magnesium sulfate 2 g in 5% dextrose in water.

Administering IV products that contain mold can cause potentially fatal infections, though so far, no injuries or illnesses have been linked to the products.

In September health officials from Tennessee and the US Centers for Disease Control and Prevention (CDC) detected fatal fungal meningitis infections that were linked to mold contamination in methylprednisolone acetate injections made by a now-shuttered Massachusetts compounding pharmacy.

The CDC is still receiving illness reports linked to New England Compounding Center. In its most recent update on Mar 11 it said the outbreak total has reached 722 cases, 50 of them fatal. The tainted injections have sickened patients in 20 states. Illnesses have ranged from meningitis to joint infections.

The outbreak has raised questions about federal and state oversight of compounding pharmacies and caught the attention of Congress, which held two hearings on the issue in November.

MedPrep Consulting said the products were used for a wide range of conditions for both hospitalized patients and outpatients. Products packed in plastic syringes were distributed nationally to physician practices and clinics, while products packed in plastic infusion bags, plastic infusion devices, plastic syringes, and glass vials were distributed to regional hospital pharmacies in New Jersey, Pennsylvania, Connecticut, and Delaware.

Meanwhile, Connecticut officials announced on Mar 16 that they are investigating the company, based on reports of products that appeared to be cloudy and possibly contaminated were delivered to a Connecticut hospital.

William Rubenstein, Connecticut's consumer protection commissioner, said in a press release from the Connecticut Department of Public Health (CDPH) that the state is working closely with the CDC, the FDA, the hospital, and the company to learn more about the scope and source of contamination.

Jewel Mullen, MD, MPH, commissioner of the CDPH, said in the statement that the state is working with the CDC to determine the possible health effects of the contamination. "We're also working with hospital officials to make sure that patients who may have received the contaminated products are notified and closely monitored."

The CDPH said the New Jersey State Board of Pharmacy announced that the company has temporarily halted all of its pharmacy operations.